| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PALINDROME | CATHETER, HEMODIALYSIS, IMPLANTED, COATED | COVIDIEN MFG SOLUTIONS S.A. | NYU | 8888145045P | 8888145045P | 1529500145 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-02 | 0 | 1. R |
Patient 1
SUBMIT DATE: 03/02/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
IT WAS REPORTED TO COVIDIEN ON 02/10/2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE INTERVENTIONALIST (IR) WAS PLACING A PALINDROME DIALYSIS CATHETER THAT RESULTED IN THE IR HAVING TO RETRIEVE THE PULL-APART SHEATH OUT OF THE RIGHT INTERNAL JUGULAR. WHEN THE DR. BROKE THE SIDES OF THE PULL-APART SHEATH AND STARTED PEELING IT AWAY, IT FELL AND WAS NOT RETRIEVABLE. THE IR DR. HAD TO SNARE IT OUT THROUGH THE GROIN.
Patient 1
A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE LOT. NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO A COMPLAINT OF THIS NATURE WERE FOUND. THE QUALITY INSPECTION OF FINAL VISUAL AND PHYSICAL EVALUATION RESULTS INDICATED THAT THE PRODUCT MET SPECIFICATION REQUIREMENTS. THE SAMPLE CONSISTED OF A PULL APART SHEATH DILATOR. THIS COMPONENT WAS RETURNED INSIDE A PLASTIC BAG WITH ITS RESPECTIVE POLYBAG AND SHOWED SIGNS OF USE. VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THAT THE TUBING WAS SEPARATED FROM THE UPPER PART OF THE VALVED SHEATH. ADDITIONALLY, IT WAS OBSERVED THAT THE TUBING OF THE SHEATH LOOK INTACT. IN ORDER TO REPLICATE THE REPORTED CONDITION, ANOTHER PULL APART WAS USED, AND AFTER THE USE AN EXCESSIVE FORCE THE TUBING WAS SEPARATED FROM THE UPPER PART OF THE VALVED SHEATH. VISUAL INSPECTION OF THE TUBING REVEALED THAT THE HOLES WERE COMPLETELY BROKEN. THE MANUFACTURING PLANT REQUESTED SAMPLES OF DILATORS WITH THE SAME LOT NUMBER AS THE PRODUCT WITH THE REPORTED ISSUE. ONE BOX WITH FIVE KITS WAS RECEIVED AND EACH ONE OF THE KITS WERE OPENED TO REVIEW THE INTEGRITY OF THE PULL APART. THE VISUAL INSPECTION REVEALED THAT THE PULL APART SHEATHS DID NOT PRESENT VISUAL ISSUES. THE FIVE PULL APARTS WERE SUBMITTED TO VISUAL, PHYSICAL, DIMENSIONAL (SHEATH PEEL FORCE) AND FUNCTIONAL (GUIDEWIRE TEST) INSPECTION BASED ON THE SPECIFICATION FOR THAT PART. ALL SAMPLES PASSED THE TESTS. THE OVERALL MOLDING CONDITION OF THE PULL APART WAS FOUND ACCEPTABLE. AN ISHIKAWA DIAGRAM WAS USED TO DETERMINE THE POTENTIAL CAUSES FOR THIS EVENT AND POSSIBLE CAUSES WERE IDENTIFIED. THIS REPORTED CONDITION HAS BEEN CONFIRMED. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT CAN BE CONSIDERED AS SUPPLIER RELATED. DURING SAMPLE EVALUATION IT WAS DETERMINED THAT EVEN THOUGH THE SAMPLE RETURNED PRESENTED SIGNS OF USE, THE TUBING WAS SEPARATED AT THE UPPER PART OF THE VALVED SHEATH WITH NO EVIDENCE OF EXCESSIVE FORCE SINCE THE HOLES OF THE SHEATH LOOKED INTACT. THIS EVENT CAN BE CONSIDERED AS AN ISOLATED EVENT. AS THIS IS A PURCHASED COMPONENT, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) IS BEING ISSUED TO HANDLE THE SUPPLIER INVESTIGATION PER PROCEDURE. NO COMPLAINT TRIGGERS OR TRENDS WERE IDENTIFIED. BASED, ON THE REQUIRED ACTION DECISION TREE, THIS COMPLAINT IS CONSIDERED AS A FAST TRACK EVENT SINCE IT IS REPORTABLE AND WAS CONFIRMED AS DEVICE (SUPPLIER) RELATED. IT MUST BE NOTED THAT IN-PROCESS CONTROLS, SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING, ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
THE CUSTOMER STATES THE INTERVENTIONALIST (IR) WAS PLACING A PALINDROME DIALYSIS CATHETER THAT RESULTED IN THE IR HAVING TO RETRIEVE THE PULL-APART SHEATH OUT OF THE RIGHT INTERNAL JUGULAR. WHEN THE DR. BROKE THE SIDES OF THE PULL-APART SHEATH AND STARTED PEELING IT AWAY, IT FELL AND WAS NOT RETRIEVABLE. THE IR DR. HAD TO SNARE IT OUT THROUGH THE GROIN.